Latest From David Wallace
Action Needed To Prevent Post-Brexit Catastrophe In Northern Ireland
Action is needed from both the UK government and the European Commission to prevent a collapse of Northern Ireland’s generics market, according to the BGMA.
PlantForm Strikes Deal For Brazilian Pembrolizumab
Canada’s PlantForm has struck a deal with Brazil’s Bio-Manguinhos/Fiocruz to develop a biosimilar pembrolizumab rival to Merck’s Keytruda for the Brazilian market and potentially beyond.
FTC Wins Backing Over Pay-For-Delay Decision
The FTC has won the backing of an appeals court over its 2019 decision that found a reverse-payment settlement deal between Impax and Endo over Opana ER to be anti-competitive and illegal.
New Fresenius Kabi Chief Sen Adds Sandoz’ Pawlu
As Michael Sen takes the reins as CEO of Fresenius Kabi, Christian Pawlu has been recruited from Sandoz to head up the firm’s generics and complex formulations unit.
Centus Settles US Litigation Over Avastin
Centus Biotherapeutics and Roche’s Genentech have agreed to settle US patent litigation over the biosimilars firm’s FKB238 proposed bevacizumab rival to Avastin.
FDA Guides On Virtual Inspections During COVID-19
Details of how the FDA plans to conduct remote evaluations of manufacturing facilities during the COVID-19 pandemic have been set out in guidance published by the US agency.